FDA user-fee reauthorization signed into law

President Trump signed the FDA Reauthorization Act of 2017 (FDARA) (H.R. 2430) into law on August 18, 2017. The law reauthorizes the FDA’s various user fee programs, which aid in funding the agency’s various oversight activities—providing over one-fourth of all FDA funding. The law extends the federal Food, Drug and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.) through fiscal year (FY) 2022 (FDA Reauthorization Act of 2017, August 18, 2017).

User fees. The FDA collects user fees from sponsors of brand name drugs, generic drugs, medical devices, and biosimilar biologics. Some exceptions apply, and no fees are collected for supplemental new drug applications and drug manufacturing facilities, classification of medical devices substantially equivalent to marketed devices, generic drug applications submitted by government entities, and supplements to generic drug applications or supplemental biosimilar applications. The new law eliminates the agency’s authority to waive or reduce medical device user fees in the interest of public health (see Bipartisan bill authorizing FDA user fees heads to the President’s desk, August 4, 2017).

Support. Various members of Congress have offered significant support for the bill. The U.S. Senate Committee on Health, Education, Labor & Pensions (HELP) noted that committee Chairman Lamar Alexander (R-Tenn) and Ranking Member Patty Murray (D-Wash) coauthored the bill, and both senators are pleased to see the bipartisan efforts to strengthen medical research continue through this new law. Several members of the House Energy and Commerce Committee offered their support of the reauthorization, as did HHS Secretary Price.

Create a PasswordPlease enter a PasswordYour password must be at least 6 characters longNo validation was done for leading or trailing spaces in password.

Yes, I would like to create an account.

I consent to the collection of my personal information by Wolters Kluwer Legal & Regulatory U.S., operated through CCH Incorporated and its affiliate Kluwer Law International, so that I can create an account to store my contact information and order history to facilitate ecommerce transactions. I understand that my personal information will be processed for this purpose in the United States where CCH Incorporated operates.

You may change or withdraw your consent at any time by contacting our Customer Service team at +1-301-698-7100 or [email protected]. For more information about our privacy practices, please refer to our privacy statement: www.WoltersKluwerLR.com/privacy.

Online subscription product purchases require that you create an account.

Email Address
This field is required
Please Type Valid Email Address
Email Address has a minimum length of 0.
Company
This field is required
Country
This field is required

Yes, send me information on similar products and content from Wolters Kluwer.

I consent to the collection of my personal information by Wolters Kluwer Legal & Regulatory U.S., operated through CCH Incorporated and its affiliate Kluwer Law International, so that I can be contacted about similar product(s) and content. I understand that my personal information will be processed for this purpose in the United States where CCH Incorporated operates. Additionally, if the products being inquired about are fulfilled by Kluwer Law International, my personal information will be shared with Kluwer Law International and processed in the Netherlands or the United Kingdom where it operates.

You may change or withdraw your consent at any time by contacting our Customer Service team at +1-301-698-7100 or [email protected]. For more information about our privacy practices, please refer to our privacy statement: www.WoltersKluwerLR.com/privacy.

Thank you!

We apologize!

Interested in submitting an article?

First Name
This field is required

Last Name
This field is required

Email Address
This field is required
Please Type Valid Email Address
Area of Expertise
This field is required
Article Idea for Consideration
This field is required

Yes, send me information on similar products and content from Wolters Kluwer.

I consent to the collection of my personal information by Wolters Kluwer Legal & Regulatory U.S., operated through CCH Incorporated and its affiliate Kluwer Law International, so that I can be contacted about similar product(s) and content. I understand that my personal information will be processed for this purpose in the United States where CCH Incorporated operates. Additionally, if the products being inquired about are fulfilled by Kluwer Law International, my personal information will be shared with Kluwer Law International and processed in the Netherlands or the United Kingdom where it operates.

You may change or withdraw your consent at any time by contacting our Customer Service team at +1-301-698-7100 or [email protected]. For more information about our privacy practices, please refer to our privacy statement: www.WoltersKluwerLR.com/privacy.

Success

We appologize

Message Us

Thank you for your inquiry! We look forward to connecting with you.

First Name
This field is required

Last Name
This field is required

Email Address
This field is required
Please Type Valid Email Address
Phone Number
This field is required
Company Name
This field is required
Country
This field is required
Topic (Optional)Account or Invoice Number (Optional)Comments (Optional)

Thank you. We will contact you soon!

We apologize, but we failed to receive this message.

Thank You!

Thank You.

Your request has been forwarded to a Wolters Kluwer representative who will contact you shortly!